Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090084
Company: ACTAVIS LABS FL INC

• REMS

Products on ANDA 090084

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE AND ASPIRIN	ASPIRIN; OXYCODONE HYDROCHLORIDE	325MG;4.8355MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090084

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2011	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2025	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/21/2024	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-12	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/03/2021	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/08/2019	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/11/2018	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/18/2018	SUPPL-5	REMS - PROPOSAL - D-N-A		Label is not available on this site.